Aerosol delivery apparatus

ABSTRACT

An apparatus and method for performing positive pressure (PP) therapy alone or in combination with an aerosol delivery apparatus. The positive pressure apparatus includes a positive pressure valve having a continuously variable respiratory window. The PP valve may be associated with a patient respiratory system interface alone, such as, but not limited to, a mask or mouthpiece, or in combination with an aerosol delivery apparatus.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.09/833,019, filed Apr. 11, 2001, now U.S. Pat. No. 6,557,549, whichclaims the benefit of U.S. Provisional Application No. 60/196,555, filedApr. 11, 2000, wherein the entirety of each of the aforementionedapplications are incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to an apparatus and method for performing PositiveExpiratory Pressure (PEP) therapy. More particularly, this inventionrelates to a method and apparatus for performing PEP therapy alone or inconjunction with an aerosol delivery apparatus.

BACKGROUND

PEP therapy is used primarily in pulmonary secretion removal. Devicesused to perform PEP therapy provide positive pressure during expiration.The patient or user exhales against a fixed orifice resistor andgenerates a pressure ranging approximately from 10-20 cm H₂O. Theresistance orifice is an important consideration and frequently isinitially set by a physician, veterinarian, or a skilled practitioner inthe art. An orifice that is too large may result in a short exhalationthat will not produce proper expiratory pressure. An orifice that is toosmall may result in a longer expiratory phase that raises the pressureabove approximately 20 cm H₂O and ultimately increases the work ofbreathing.

During the exhalation phase of PEP therapy, the airway is splinted openby the pressure. This causes the movement of secretions from theperipheral airways into the larger airways where they can be expelled.PEP therapy usually lasts for about 10-20 minutes and is performed asrequired, generally 1-4 times per day. Typically, the patient performs10-20 PEP breaths, removes the device from their mouth and follows thiswith a forceful exhalation. This final exhalation triggers a cough thatloosens secretions.

Studies indicate that PEP therapy dilates the airways and improves thedistribution of ventilation, resulting in a better deposition of aninhaled substance, such as, but not limited to, a medicine or remedy. Asused herein, the term “aerosol delivery apparatus” means any apparatuscapable of producing and/or delivering a substance, such as, but notlimited to, a medicine, in a form suitable for inhalation by a patientand includes, without limitation, an aerosol holding chamber, nebulizer,spacer with integrated actuator, a dry powder inhaler, and a metereddose inhaler.

SUMMARY OF THE INVENTION

One aspect of the present invention is directed to a positiverespiratory pressure apparatus including a patient respiratory systeminterface and a valve assembly in fluid communication with the patientrespiratory system interface. The valve assembly has a valve configuredto pass a fluid traveling in a predetermined direction from a first sideto a second side of the valve, and a variable resistance bypass windowpositioned adjacent the valve and having a resistance to a fluidtraveling in a direction opposed to the predetermined direction, wherethe variable resistance bypass window is continuously adjustable betweena first fluid resistance and a second fluid resistance.

According to another aspect of the invention an apparatus is disclosedthat is capable of performing positive expiratory pressure (PEP) therapyalone or in combination with providing a substance, generally in aerosolform. The apparatus includes a positive pressure (PP) valve having acontinuously variable respiratory window. As used herein, the termrespiratory is intended to encompass both inhalation and exhalation.Whether inhalation resistance or exhalation resistance is called forwill be known to one skilled in the art. The valve may be located at ornear the output end of an aerosol delivery apparatus. U.S. applicationSer. No. 08/938,686 filed Sep. 26, 1997 in the name of Engelbreth et al.and Ser. No. 09/287,997 filed on Apr. 7, 1999 in the name of Schmidt etal. describe exemplary embodiments of an aerosol delivery apparatus andthe disclosures of these references are incorporated herein byreference. Further, U.S. Pat. No. 4,470,412 to Nowacki et al.,describing a spacer or expansion chamber, is additionally incorporatedherein by reference. The aerosol delivery apparatus with the PPapparatus may be used alone or in combination with a mask or mouthpiece.

In one embodiment, the PP apparatus is associated with a mask. The maskwith the PP apparatus may be used alone or in combination with anaerosol delivery apparatus. In another embodiment, the PP apparatus isassociated with a mouthpiece. The mouthpiece with the PP apparatus maybe used alone or in combination with an aerosol delivery apparatus. In afurther embodiment, the PP apparatus is associated with a nebulizer. Thenebulizer with the PP apparatus may be used alone or in combination witha patient respiratory system interface, such as a mask or mouthpiece. Inyet another embodiment, the PP apparatus is associated with a spacerchamber with an integrated actuator. The spacer chamber with theintegrated actuator associated with the PP apparatus may be used aloneor in combination with a mouthpiece or mask.

In another embodiment, a pressurized metered dose inhaler canister iscapable of association with an aerosol holding chamber having a PP valveassociated therewith. In yet a further embodiment, a pressurized metereddose inhaler canister is capable of association with an aerosol holdingchamber engageable with a mouthpiece or mask having a PP valveassociated therewith.

Another aspect of the invention is directed to a kit for performingpositive expiratory pressure including an aerosol delivery apparatus, amouthpiece and/or mask attachable to the output end of the aerosoldelivery apparatus, and a PP apparatus. The PP apparatus may be locatedon the aerosol delivery apparatus or the mouthpiece and/or mask. Inalter- native embodiments, the PP apparatus may be attached to theaerosol delivery apparatus or integrally formed with the apparatus. Theaerosol delivery apparatus, mouthpiece, and PP valve can be combined soas to accomplish positive expiratory therapy and administration of asubstance, such as, but not limited to, a medicine in aerosol form. Anyaerosol delivery apparatus may be used. In further embodiments of thekit, a backpiece is included for association with an aerosol deliveryapparatus. A pressurized metered dose inhaler can engage with thebackpiece for delivery of a medicament.

One embodiment of a method of performing positive expiratory pressuretherapy includes providing a PP apparatus with a valve that is capableof providing a continuously variable expiratory window. The methodfurther includes performing a series of breaths. When exhalation isperformed, the exhalant is directed through the continuously variableexpiratory window. Performance of a therapeutic cough triggers theloosening of secretions. Upon loosening of the secretions, a substance,such as a medicament, may be provided for inhalation into therespiratory system. In an alternative embodiment of method, the PP valvemay be positioned so as to provide positive inspiratory pressure uponinhalation into the apparatus.

A further aspect of another embodiment includes association of a PPapparatus associable with a mask or mouthpiece engageable with abackpiece device. The backpiece device includes a plastic or anelastomeric adapter suited to receive the mouthpiece of a pressurizedmetered dose inhaler.

One embodiment of a method of performing positive expiratory pressuretherapy includes providing a positive expiratory pressure apparatushaving a valve capable of providing a continuously variable resistancewindow, performing a series of breaths including inhalation andexhalation; exhaling so that the exhalant is directed through thecontinuously variable resistance window, performing a therapeutic coughtriggering the loosening of secretions, and providing an inhaleablemedicament.

Another embodiment of a method of performing positive expiratorypressure therapy includes providing a positive respiratory pressureapparatus having a valve capable of providing a continuously adjustableresistance to exhalation, where the valve is located in a mouthpieceattachable to a chamber. A patient then executes a series of therapeuticbreaths, including inhalation and exhalation, wherein the exhalant isdirected through the continuously adjustable resistance window, thepatient performs a therapeutic cough triggering the loosening ofsecretions, and medicament is provided via the chamber.

According to another aspect of the invention, a method of performingpositive expiratory pressure therapy in combination with providing anaerosolized medicament includes providing a positive expiratory pressureapparatus having a positive expiratory pressure valve capable ofproviding a continuously variable resistance window, where the valve ispositionable in a mouthpiece and the mouthpiece attachable to an aerosolholding chamber. A series of therapeutic breaths, including inhalationand exhalation, are then taken where the exhalant is directed throughthe continuously variable resistance window. The continuously variableresistance window is preferably capable of providing a variable backpressure to the exhalant. A therapeutic cough capable of triggering theloosening of sections is performed and aerosolized medicament from theaerosol holding chamber is administered through inhalation.

One embodiment of an apparatus capable of performing positiverespiratory pressure therapy in combination with providing anaerosolized medicament includes a positive respiratory pressure valvehaving a continuously variable resistance window; and an aerosol holdingchamber having an output end, the positive respiratory pressure valvelocatable at the output end.

Another embodiment of an apparatus capable of performing positiverespiratory pressure therapy includes a positive respiratory pressurevalve having a slide control, the slide control providing a continuouslyvariable resistance window; and a mouthpiece, the mouthpiece having afirst and a second end, the second end capable of association with thepositive respiratory pressure valve.

Yet another embodiment of an apparatus capable of performing positiverespiratory pressure therapy in combination with providing anaerosolized medicament includes a positive respiratory pressure valvehaving a continuously variable resistance window; an aerosol holdingchamber having an input end and an output end, the positive respiratorypressure valve locatable at the output end; and a metered dose inhalercanister capable of association with the input end of the aerosolholding chamber.

A still further embodiment of a kit for performing positive expiratorypressure includes an aerosol holding chamber having an inlet and anoutlet. A backpiece is attachable to the inlet of the aerosol holdingchamber with a metered dose inhaler capable of association with thebackpiece. A mouthpiece is attachable to the outlet of the aerosolholding chamber. A positive expiratory pressure valve is generallylocatable at the outlet end of the aerosol holding chamber, wherein theaerosol holding chamber, backpiece, mouthpiece, and positive expiratorypressure valve can be combined so as to accomplish positive expiratorytherapy and administration of an aerosolized medicament.

An additional embodiment of an apparatus capable of performing positiveexpiratory pressure therapy in combination with providing an aerosolizedmedicament includes a positive expiratory pressure valve having acontinuously variable resistance window, a mouthpiece, the positiveexpiratory pressure valve associable with the mouthpiece, and anebulizer having an input end and an output end, the positive expiratorypressure valve associable with the output end.

Further embodiments include a mouthpiece wherein the improvementcomprises a positive pressure valve. An additional embodiment includes anebulizer wherein the improvement comprises a positive pressure valve.Moreover, an embodiment includes an aerosol holding chamber wherein theimprovement comprises a positive pressure valve. A yet furtherembodiment includes a pressurized metered dose inhaler wherein theimprovement comprises a positive pressure valve.

The invention will best be understood by reference to the followingdetailed description of the preferred embodiment, taken in conjunctionwith the accompanying drawings. The discussion below is descriptive,illustrative and exemplary and is not to be taken as limiting the scopedefined by any appended claims.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a cross sectional view of a mouthpiece associable with achamber in conjunction with a PP apparatus.

FIG. 2 is a perspective view of a mouthpiece associable with a chamberin conjunction with the PP apparatus.

FIG. 3 is an exploded view of the preferred embodiment.

FIG. 4a is a front view of one embodiment of the PP apparatus.

FIG. 4b is a cross section drawn along line A-A of FIG. 4a .

FIG. 4c is a back view of one embodiment of the PP apparatus.

FIG. 4d is a cross section drawn along line B-B of FIG. 4a.

FIG. 4e is a sectional cross section drawn along line C-C of FIG. 4a.

FIG. 4f is a rear perspective view of the embodiment of FIG. 4a.

FIG. 5 is a rear perspective of a mouthpiece according to a preferredembodiment.

FIG. 6 is a front perspective view of a mouthpiece with one embodimentof the PP apparatus.

FIG. 7a is a front view of the fitting and manometer port.

FIG. 7b is a cross section drawn along line A-A of FIG. 7a of thefitting and port.

FIG. 8a is a top view of one embodiment of the slide control.

FIG. 8b is a side view of one embodiment of the slide control.

FIG. 8c is a perspective view of one embodiment of the slide control.

FIG. 8d is a cross section drawn along line A-A of FIG. 8a.

FIG. 9 is a top perspective view of one embodiment of the slide control.

FIG. 10 is a perspective view of an alternative embodiment of the PPapparatus of FIGS. 1-3 showing detent notches in conjunction with amouthpiece.

FIG. 11 is an exploded view of one embodiment showing a slide controlhaving a port.

FIG. 12 is one embodiment of the slide control having a port.

FIG. 13 is one embodiment of the mouthpiece showing the annular sealingring.

FIG. 14 is one embodiment showing a plurality of detent notches.

FIG. 15 is a side view of one embodiment of the control valve showingthe port.

FIG. 16 is a concave perspective view of the slide control showing theport.

FIG. 17 is a concave bottom view of the slide control showing the port.

FIG. 18 is an exploded view of an alternative embodiment of the PPapparatus of FIGS. 8-10.

FIG. 19 is a cross-sectional view of the PP apparatus of FIG. 18.

FIG. 20 is a perspective view of a duck-bill valve used in the PPapparatus of FIGS. 18-19.

FIG. 21 is a cross-sectional view of the duck-bill valve of FIG. 20.

FIG. 22a is a front exploded view of one embodiment of the PP apparatusin conjunction with a mouthpiece and associable with a spacer.

FIG. 22b is a rear exploded view of one embodiment of the PP apparatusin conjunction with a mouthpiece and associable with a spacer.

FIG. 22c is a front view of one embodiment of a valve showing thebaffle.

FIG. 23 is a perspective view of one embodiment of a PP apparatus inassociation with a nebulizer.

FIG. 24 is an exploded view of one embodiment of the PP apparatus and amouthpiece.

FIG. 25 is a perspective view of one embodiment of the PP apparatus inan open position and a mouthpiece.

FIG. 26 is a perspective view of one embodiment of the PP apparatus in asemi-open position and a mouthpiece.

FIG. 27 is an exploded view of one embodiment of the PP apparatusshowing the disc and a mouthpiece.

FIG. 28a is a top view of one embodiment of the PP apparatus and amouthpiece.

FIG. 28b is a cross section of one embodiment of the PP apparatus and amouthpiece showing a plurality of prongs holding the PP apparatus.

FIG. 29 is an exploded view of a PP apparatus associated with amouthpiece and having an inhalation valve.

FIG. 30 is an exploded view of a PP apparatus associated with amouthpiece and having an exhalation valve.

FIG. 31 is a further perspective view of one embodiment of the PPapparatus in conjunction with a mask having an opening for associationwith a chamber.

FIG. 32a is a close up of one embodiment of the PP apparatus in a fullyopen position in conjunction with a mask.

FIG. 32b is a cross section of one embodiment of the PP apparatus in afully open position in conjunction with a mask.

FIG. 33a is a close up of one embodiment of the PP apparatus in apartially open position in conjunction with a mask.

FIG. 33b is a cross section of one embodiment of the PP apparatus in apartially open position in conjunction with a mask.

FIG. 34a is a close up of one embodiment of the PP apparatus having aplurality of variable sized flow ports, in conjunction with a mask.

FIG. 34b is a cross section of one embodiment of the PP apparatus havinga plurality of variable sized flow ports, in conjunction with a mask.

FIG. 35a is a front exploded view of a close up of one embodiment of thePP apparatus having a plurality of variable sized flow ports, inconjunction with a mask.

FIG. 35b is a rear exploded view of a close up of one embodiment of thePP apparatus having a plurality of variable sized flow ports, inconjunction with a mask.

FIG. 36 is a front view of one embodiment of the PP apparatus showingresistance setting indicia.

FIG. 37 shows a perspective view of a spacer for a pressurized metereddose inhaler with one embodiment of the PP apparatus.

FIG. 38a is a perspective view of one embodiment of the resistancewindow in the open position.

FIG. 38b is a perspective view of the embodiment of FIG. 38a with theresistance window in a closed position.

FIG. 39a is a perspective view of one embodiment of the resistancewindow in the open position.

FIG. 39b is a perspective view of one embodiment of the resistancewindow in the closed position.

FIG. 40 illustrates an alternative embodiment of the apparatus of FIGS.37-39.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

FIGS. 1-3 show one embodiment of an assembly 10 for performing positiveexpiratory pressure (PEP) therapy where the assembly incorporates apositive pressure (PP) device having a PP valve 12. The assembly 10includes an aerosol delivery apparatus, such as an aerosol holdingchamber 14, and a patient respiratory system interface, such as amouthpiece 16 and/or mask attachable to the output end of the aerosoldelivery apparatus. The PP valve 12 may be located on the aerosoldelivery apparatus or the patient respiratory system interface. Theassembly 10 combines the aerosol delivery apparatus, mouthpiece, and PPvalve into a tool for use in both positive expiratory therapy andadministration of a substance, such as a medicament, in aerosol form.Any aerosol delivery apparatus suitable for generating an aerosol of thedesired substance may be used.

In the embodiment of FIGS. 1-3, a backpiece 18 is attachable to theinlet 20 of the aerosol holding chamber 14. A metered dose inhaler (notshown) may be connected with the backpiece 18. The mouthpiece 16 isattachable to the outlet end 22 of the aerosol holding chamber 14. ThePP valve 12 is generally locatable at the outlet end 22 of the aerosolholding chamber 14. FIG. 3 depicts an exploded view of the PEP assemblyshowing an annular valve 24 positioned between the outlet end 22 and themouthpiece 16. More details on the aerosol holding chamber 14 disclosedin FIGS. 1-3 may be found in U.S. Pat. No. 4,470,412 and U.S. patentapplication Ser. No. 09/287,997 incorporated above.

In the embodiment depicted in FIGS. 1 and 2, the aerosol holding chamber14 is provided with an annular valve 24 located at its outlet end 22.The annular valve 24 allows the user to inhale medicament from thechamber 14, but prevents exhalation back through the chamber. Asillustrated in FIGS. 1-3, and in more detail in FIGS. 4a-4f, 5 and 6, aPP valve 12 may be formed in a mouthpiece 16. The PP valve 12 includes aslide control 26 that is movably positioned relative to a resistancewindow 28. The slide control 26 is variably maneuverable to cover oruncover the resistance window 28 in a continuous manner. Further, themovement of the slide control 26 includes, but is not limited to,covering or uncovering, and/or opening or closing, the resistance window28 or any variations thereof.

The PP valve 12 may be located on or in conjunction with a mouthpiece16. An exemplary embodiment of the mouthpiece 16 shown in FIGS. 4a-4fhas a distal end 30 and a proximal end 32. Commonly, the proximal end 32of the mouthpiece is inserted or associated with the mouth or nostrilsof the user. Additionally, the distal end 30 of a mouthpiece may or maynot be associated with an aerosol delivery apparatus and the mouthpiecealone may be configured to constitute a PEP device.

Generally, in one exemplary embodiment, the PP valve 12 may be locatedat or near the distal end 30 of the mouthpiece 16. Although, it isunderstood that the PP valve 12 may be located anywhere on themouthpiece 1 and its location is not to be limited. In an alternativeembodiment, the PP valve 12 may be located at or near the output end 20of the aerosol delivery apparatus, such as, but not limited to, theaerosol holding chamber 14 of FIGS. 1-3. Generally, the direction oftravel of any fluid, particularly an aerosol or nebulizer medicament, isin the direction from the input end 20, through the channel or chamberbody, and to or out the output end 22. This direction of travel frominput end 20 to output end 22 is referred to as travel from downstreamto upstream.

In a preferred embodiment the mouthpiece 16 is formed of plastic. Theplastic may be either rigid or soft. Other materials that can also beused for the mouthpiece 16 include metal or other materials known to onein the art. In the embodiment depicted in FIGS. 1-3, 4a, 4b, 4c, and 4f,a tab 34 is provided allowing for the connection of a cap 36, as shownin FIG. 2, to cover the proximal end 32 of the mouthpiece 16. In apreferred embodiment, the mouthpiece 16 may include indicia 35, orsetting indications, representing the resistance setting. The indicia 35may be in the form of numbers, bars, colors, a series of dots or thelike.

In a further embodiment, as shown in FIGS. 7a and 7b, the PP apparatus10 may includes a fitting 39 sized for placement over the proximal endof the mouthpiece. The fitting 39 includes a manometer port 41 extendingfrom the fitting over which a manometer can be attached. In a preferredembodiment the fitting 39 is formed of a plastic. The plastic may beeither rigid or soft. Other materials that can also be used to form thefitting include metal.

FIGS. 3, 8a-8d and 9 show an embodiment of the slide control 26 of thePP apparatus 10. As shown in FIG. 9, in the illustrated embodiment, theslide control 26 is of a semi-circular, quarter moon shape. The slidecontrol 26 has a first lateral side 38 concave in shape and a secondlateral side 40 opposite the first side 38. The slide control 26 alsohas a top 42 and a bottom 44 surface. From the top surface 42 of theslide control 26 extends a tab setting 46.

In the illustrated embodiment, the tab setting 46 is a uniformly moldedprojection from the slide control 26. In a preferred embodiment, the tabsetting 46 has smooth edges for easy engagement with the finger, thumbor appendix of the user. The tab setting 46 may also have a serratededge or any other edge known in the art. When assembled with themouthpiece 16, the tab setting 46 projects through the mouthpiece fromthe tab window 48. The user of the device manipulates the tab setting 46in such a manner as to cause, either directly or indirectly, themovement of the slide control 26 thereby varying the opening of theresistance window 28.

In the embodiment of FIGS. 1-3, 4a-4f, 5 and 6, the tab window 48 isarcuate in shape, parallel to the contour of the circumference of themouthpiece 16. Referring to FIG. 4f, the slide control 26 is preferablyseated in a channel 50 located on the mouthpiece 16. The slide control26 is held within the channel 50 by at least one tooth 52. Located onone or both of the walls of the channel 50 is a stepped surface 54 asshown in FIG. 5.

In the embodiment shown in FIGS. 8a and 6, the control arm 56 of theslide control 26 is shown having a finger protection 58 from one end ofthe slide control 26. In another embodiment, the slide control 26 mayhave a control arm 56 located on both ends of the slide control 26. Thefinger projection 58 is capable of engagement with the stepped surface54 inside the mouthpiece shown in FIGS. 4c and 5. In the illustratedembodiment, the stepped surface 54 includes a series of ribs extending avariable length of the internal diameter of the mouthpiece 16. Inanother embodiment, as shown in FIG. 30, the stepped surface 54 may alsobe located along the tab window 48. Therefore, the location of thestepped surface 54 may vary while remaining engageable by the controlarm 56. Additionally, the stepped surface 54 may be located on either orboth of the internal walls of the channel 46. In the embodiment of FIGS.4a-4f and 8a-8d, the slide control 26 is of a flexible material so thatthe control arm 56 can slide across the uppermost surface of the ribsprojecting from the stepped surface 54. When the desired opening of theresistance window 28 is obtained, the control arm 56 engages in asemi-locked manner the ribs projecting from the stepped surface 54.

The end of the slide control 26 opposite the control arm 56 may eitherbe provided with a finger projection 58 or may be smooth. The length ofthe slide control 26 extending from the tab setting 46 to the end of thecontrol arm 56 opposite the projection 58 is generally the length of theresistance window 28. This resistance control length 60 is at least thelength that the resistance window 28 can be opened allowing for exhalantto exit the window 28. In a preferred embodiment, the slide control 26is manufactured of a plastic. The plastic may be either rigid or soft.Other materials that can also be used for the slide control 26 includemetal or other materials known in the art.

In general, as shown in FIG. 5, the resistance window 28 may be anopening of any size or shape in the walls defining the channel 46 in themouthpiece 16 which, in conjunction with the illustrated embodiment ofthe slide control 26, provides an opening in the mouthpiece 16 toproduce sufficient pressure during exhalation of the patient performingPEP therapy. For example, the resistance window 28 may be formed withstraight or slanted edges. If the edges are slanted, this provides asteeped effect to the resistance window 28. If the desired exhalationpressure is determined to range from 10-20 cm H₂O, then the resistancewindow 28 in conjunction with the slide control 26, acting as a cover orclosure mechanism for the resistance window 28, are sized in such amanner as to provide an appropriate opening for the desired exhalationpressure to be produced. As one example, if the resistance window 28 isgenerally narrow, then the length of the window may be of a longerlength so as to provide a large enough opening through which PEP therapyis performed. Interdependent in the relationship is the resistancewindow length 60 of the control arm 26. In the above example, theresistance window length 60 of the control arm 26 is generally longer tocover the desired amount of the resistance window 28. The control arm 26may provide a continuously adjustable variable resistance window betweena first position where the control arm completely blocks the window 28,to a second position where the control arm leaves the window completelyopen.

An alternative embodiment of an assembly 100 for performing PEP therapyis shown in FIGS. 10-17. This embodiment is similar to the embodiment ofFIGS. 11-13, but utilizes a variation of the resistance window and slidecontrol in the PP valve 112. In the assembly 100 of FIGS. 10-17, theresistance window 128 and slide control 126 are positioned in themouthpiece 116. The tab setting 146 of the slide control 126 is of aflexible material. A detent 158 protrudes from the first tab settingface 156 located on the concave side 125 of the slide control 126. Asshown in FIG. 15, a position indicating rib 159 is located on the tabsetting 146 opposite the detent 158. In the illustrated embodiment, therib 159 is shown as a generally rectangular protrusion from the surfaceof the tab setting 146. Yet, the rib 159 may be any shape protrusion,such as but not limited to circular, triangular. Further, the rib 159may not be a protrusion at all but rather is a concave marking on thesurface of the tab setting 146. The rib 159 has at least the function ofindicating to the user the extent of the opening of the resistancewindow 128. Therefore, one skilled in the art can envision a variety ofmarking, shapes, indents or protrusions, or colors which serve at leastthe function of indicating the extent of the opening of the resistancewindow 28.

The detent 158 located on the tab setting 146 is associated with atleast one detent notch 154 as shown in FIGS. 10 and 14. The flexible tabsetting 146 is movable within the tab window 148. The one or more detentnotches 154 are preferably located along the boundary of the tab window148 and indicia 135, representative of exhalation effort correspondingto the position of the slide control 126, are arranged adjacent therespective detent positions. FIGS. 10 and 14 show a plurality of detentnotches 154. In operation, the flexible tab setting 146 is moved alongthe tab window 148. The detent 154 located on the first tab fitting face125 of the tab setting 146 moves into and out of engagement with thedetent notches 154. Movement along the boundary and engagement with thedetent notches 154 removably fixes the slide control 126 in a variety ofpositions. Each varied position provides for a further opening orclosing of the resistance window 128. Further, in operation, the detent158 is not limited to being engaged with a detent notch but may beengaged or seated at any point along the boundary. Engagement with, orseating within, a detent notch 154 of a detent 158 provides for avariable securely fixed opening of the resistance window 128. Eachdetent notch 154 may correspond to a particular size opening or pre-setopening of the resistance window 128. Therefore, by engagement of thedetent 158 within the detent notch 154, the user may be provided with apreset resistance window opening 128. Yet, the detent notch 154 may alsobe positioned anywhere along the boundary providing for a continuouslyvariable resistance window opening 128.

The slide control 126, as shown in FIGS. 15, 16 and 17 has locatedtherein a port 143. The port 143 may be of any size or shape and in theillustrated embodiment is generally a rounded triangle having anelongated point. The port 143 operates in conjunction with theresistance window 128. In the embodiment illustrated in FIGS. 10-17, thesize of the opening through which the exhalant passes is determined byhow much of the port 143 is left uncovered or open and aligned with theresistance window 128. The slide control 126 is provided with a closurearea 145, as shown in FIG. 16. Further, the slide control 126 isprovided additionally with a port area 160. When the resistance window128 is closed or not open and thereby not allowing for the exiting ofany exhalant, the closure area 145 of the slide control 126 is congruentwith or aligned with the resistance window 128. As the slide control 126is gradually moved, the port area 160 containing the port 143 is broughtinto alignment with the resistance window 128 in the mouthpiece 116. Inthis manner, a continuously variable opening is provided. For example,as the slide control 126 moves aligning a greater and greater amount ofthe port 143 with the resistance window 128, a greater opening or pathfor the exhalant is provided.

As described above, and similar to the embodiment of FIGS. 1-3, theslide control 126 is seated in a channel 150 located on the mouthpiece116. The slide control 126 is slidably movable within the channel 150 inthe manner described above so as to continuously variably align the port160 with the resistance window 128. In the embodiment of the slidecontrol 126 illustrated in FIGS. 13, 16, and 17, a retaining ridge 162fits into the channel 150 thereby holding the slide control 126 in itsdesired position throughout its range of motion in the mouthpiece. Thedesired position of the slide control 126 is as close as possible to theannular sealing ring 164 shown in FIG. 13. One function of the annularsealing ring 164 is to prevent leakage of the exhalant to ensure thatthe exhalant to the greatest extent exits from the resistance window128. In a further embodiment, the PP valve 112 may optionally beprovided with at least one locating ring or post 166 to help maintainthe slide control 126 in alignment. As with the embodiment of FIGS. 1-3,a patient's exhalation effort is controlled by adjusting the slidecontrol over the resistance window so that the patient's exhaled air,which is prevented from entering the aerosol chamber 114 by the annularvalve 124 and a baffle (not shown), must exit through the resistancewindow and provide a desired exhalation resistance. More specifically,during inhalation the inner diameter 127 of the annular valve 124 (FIG.11) unseats from the baffle (not shown) on the output end 122 of theaerosol holding chamber and permits passage of fluid. Substantiallysimultaneously, the exhalation flange 186 of the valve 124 flexes toseal against the outer ridge 188 (FIG. 13) formed inside the mouthpiece116 to prevent ambient air from entering the mouthpiece. Duringexhalation, the process is reversed and the inner diameter 127 preventsexhalant from entering the aerosol holding chamber while the exhalationflange 186 flexes away from the outer ridge 188. Thus, the exhalantpreferably passes through the resistance window 128 and may escape tothe outside between the exhalation flange and the mouthpiece, and thenthrough the gap between the mouthpiece and aerosol holding chamber.

Referring to FIGS. 18-21, an alternative embodiment of an assembly 210for PEP therapy combined with an aerosol delivery apparatus is shown.The aerosol delivery apparatus includes a chamber housing 214 having aninput end 220 and an output end 222. The chamber housing 214, input end220, and output end 222 define an interior space 223. The apparatus mayalso include an elastomeric backpiece which may be similar to thebackpiece in the embodiment shown in FIGS. 1-3. The output end 222 ofthe chamber housing 214 is shaped to receive the mouthpiece 216 andincludes locking tabs 281 and a protrusion 283. The protrusion 283 ispreferably annular in shape. The locking tabs 281 are spaced apartaround the outside of the output end 222.

Referring to FIGS. 18-19, the mouthpiece assembly 216 is preferablysubstantially similar to that illustrated in FIGS. 10-15. The mouthpieceassembly includes an annular sealing ring 224, and a resistance windowdefined by a gap 225 in the sealing ring. A slide control 226 isslidably seated in a channel 250 between the annular sealing ring andsupport posts or a support ring. The tab setting 246 protrudes from thetab window 248 in the mouthpiece 216. The continuously variableresistance function is achieved as described above, using eitherembodiment of slide control and nozzle described above.

The mouthpiece assembly 216 is connected to the output end 222 of thechamber housing 214 by placing the apertures 284 over the locking tabs281. As with the embodiment of FIGS. 1-3 and 10-17, in the embodiment ofFIGS. 18-21 a containment baffle 275 may be integrally formed with thechamber housing 214 from a single piece of material and located near theoutlet end 222. As shown in FIG. 18, the containment baffle 275 includesconnecting members 276 that extend from the edge of the containmentbaffle to the inner diameter of the output end 222 in the chamberhousing. Vents 277 are defined between the outer perimeter of thecontainment baffle and the inner diameter of the outlet end of thechamber housing and are separated by the connecting members. The vents277 are arcuate in shape and conform to the outer perimeter of thecontainment baffle 275. In a preferred embodiment, the containmentbaffle is dome-shaped where the concave end points towards the chamber223. In alternative embodiments, the containment baffle may be any of anumber of geometric shapes.

A valve 278 having a valve member 279 and a valve seat 280 is shown. Thevalve seat 280 preferably comprises the rim of the valve and thecorresponding raised lip 283 on the outlet end 222 of the chamberhousing 214. The valve member has a sealing surface that preferablyforms between two parallel portions, or lips, of the valve. In apreferred embodiment, the valve material seals against itself when fluidflows against a predetermined flow direction of the valve. In theembodiment shown, the valve is a duck-bill valve where the valve seat280 is positioned axially away from the valve opening. The valve 278defines a central open area toward the end having the valve seat. Thevalve member 279, shown as parallel sealing lips in FIGS. 18-21, acts toallow passage of fluid on inhalation, but upon exhalation, the lips ofthe valve member are held together by the force of fluid (e.g. exhaledair) pressing against the walls 285 of the valve member and collapsingthe lips of the valve member 279 against each other in a closedposition. The valve seat 280 also provides a seal against the chamberhousing 214 during exhalation so that exhalant from a patient must bedirected through the continuously variable resistance window in themouthpiece.

In one preferred embodiment, the duck-bill valve 278 has a central openarea 274 at its base that has a diameter of approximately 26.09millimeters (mm). The width of the lips that form the valve member 279is approximately 21.35 mm and the angle at which the walls 285 convergeis approximately 72 degrees. Also, the height of the duck-bill valve 278measured from the upper portion 282 of the valve seat to the valvemember 279 is approximately 18.8 mm. The mouthpiece 216 for containingthis valve 278 preferably includes a resistance widow gap 225 having alength of 59 degrees of arcuate cut in the annular sealing ring 224,where the annular sealing ring is approximately 31.4 mm in diameter andhas a height of 4.5 mm.

The operation of the apparatus will now be discussed generally withreference to the embodiments of FIGS. 1-3, 10-17 and 18-21. At rest, thevalve is adjacent to the output end of the chamber housing. In theannular valve embodiment of FIGS. 1-3 and 10-17 the inner portion of thevalve covers the vents at the outlet end of the chamber housing. In theduck-bill embodiment of FIGS. 18-21, the entire outlet end is covered bythe valve. For either valve embodiment, the mouthpiece and outlet end ofthe chamber housing traps the valve in place. Inhalation by the patientcauses the sealing portion of the annular valve to move, oralternatively the lips of the duckbill valve to separate, and permitfluid to pass. Fluid from the chamber housing may be inhaled into thepatient's respiratory system through the mouthpiece. The patient maythen exhale into the mouthpiece.

Exhalation by the patient results in air traveling through themouthpiece in a direction opposite the predetermined inhalation flowpath of the valve. This air, which is blocked from passage through thevalve along the inhalation path, then passes along a second path throughthe resistance window in the mouthpiece. Also, the force of the exhaledair causes the outer portion of the valve to move away from themouthpiece in a direction towards the chamber housing. As a result, anexhalation pathway is created between the outer portion of the valve andthe mouthpiece through which the exhaled air passes out to theatmosphere or some other predetermined location. As described above, theamount of effort that exhalation requires is set by the slide control,which may be set to block the appropriate amount of the resistancewindow to achieve the desired resistance.

Referring specifically to the duck-bill valve embodiment of FIGS. 18-21,the duck-bill valve 278 assists both in preventing inhalation of ambientair through the resistance window 225 and providing an exhalation pathfor exhalant. When the apparatus 210 is assembled (FIG. 19), the upperportion 282 of the valve seat seals against the annular sealing ring 224except for the gap in the annular sealing ring 224 defining theresistance window 225. During inhalation, fluid flows through thecentral opening 274 and out the lips of the valve member 279. Also, theexhalation flange 286 flexes toward the proximal end of the mouthpieceand provides a secondary seal against the outer ridge 288 inside themouthpiece. The outer ridge 288 is preferably continuous around theinner circumference of the mouthpiece. Upon exhalation, the lips of thevalve member 279 close, the exhalant passes through the resistancewindow under the upper portion 282 of the valve seat positioned adjacentthe resistance window opening, and the exhalation flange flexes awayfrom the outer ridge 288 and out between the aerosol holding chamber 214and mouthpiece 216.

As shown in FIGS. 22a-22c, an embodiment of an apparatus 310 forperforming PEP therapy is disclosed that may be used with or without anaerosol delivery apparatus. In contrast to the embodiments discussedabove, the PEP apparatus of FIGS. 22a-22c is a standalone PEP device ina mouthpiece incorporating the previously discussed continuous variableresistance window with slide control, and variations thereof, along witha self contained valve 378 that may be similar to that disclosed in theprevious embodiments. Thus, the valve 378 need not be found on theoutlet end of a separate chamber extension 314 but may be positioned onthe distal end 330 of the mouthpiece. As best shown in FIGS. 22b-22c,the valve 378 may be an annular valve. The 378 is preferably retainedtoward the distal end 330 of the apparatus by a central baffle 385supported by radial spokes 386. In one embodiment, the PEP apparatus 310is formed of an attachable mouthpiece section 316 and a baffle section317. The mouthpiece and baffle sections 316, 317 may be removably joinedusing snap-fit, threaded or other known attachment schemes. In anotheralternative embodiment, the mouthpiece and baffle sections 316, 317 maybe integrally molded or welded shut to form a non-removable, unitarypiece. An extended inlet 314, without any valves, may be used with thestand-alone PEP device 310 to enhance delivery of any medicine to thepatient's respiratory system. One function of the extended inlet is toprovide a chamber for the dispensed particles from the pressurizedmetered dose inhaler. When desired, a pressurized metered dose inhalermay be coupled to the extended inlet with a backpiece and medicamentsupplied from the pressurized metered dose inhaler can be delivereddirectly to the user.

Although the embodiments of FIGS. 1-22 illustrate annular and duck-billvalves 24, 124, 278, 378, any of a number of other valve configurationsmay be used. A preferred valve is capable of passing a fluid moving in afirst direction along a first path and also capable of passing a fluidmoving in an opposite direction along a second path. In the examplevalves discussed above, inhalation draws fluid through a central openingin the valve while the perimeter of the valve prevents fluid flow. Inthe above examples, exhalation closes the path through the centralopening and directs fluid along a second path around the perimeter ofthe valve. Other paths may also be used.

FIGS. 23-28 illustrate another embodiment of a PEP apparatus 410. Asbest shown in FIG. 23, the PEP apparatus 410 has a patient respiratorysystem interface, such as a mouthpiece 416, on a proximal end 432 andmay be connected with an aerosol delivery apparatus, in this example anebulizer 414, at a distal end 430. The PEP apparatus includes a PPvalve 412 positioned on top of the mouthpiece 416. The PP valve 412preferably consists of a cover 417 that may be removably attached to areceiving area 419 (FIG. 24) on the mouthpiece 416. The cover has aresistance window 428 and a tab window 448 extending through a topsurface. A slide control 426 in the form of a disk with vents 460extending through the thickness of the disk is movably positioned underthe cover 417. A one-way valve 423 is positioned between the slidecontrol 426 and the top of the mouthpiece 416 to allow air exhaled intothe proximal end 432 to escape through the resistance window 428 whilepreventing any air from entering through the resistance widow duringinhalation.

In FIGS. 23-28, the resistance window 428 is shown generally as apie-slice shaped cut-out with the point of the pie-slice removed so asto form a concave edge. The resistance window 428 may be any shape andshould not be limited by the illustrated embodiment. Further, aplurality of resistance windows 428 may form the PP valve 412. Thenumber of windows 428 is not intended to be limited by the illustratedembodiment. In the illustrated embodiment of FIGS. 23-28, andparticularly FIG. 27, the slide control 426 is shown as a circular dischaving a pie-slice shaped cut-outs with the point of the pie-sliceopenings therein which correspond to the openings of the resistancewindow 428. In operation, aligning the openings 460 of the disc with theresistance window 428 controls the opening of the continuously variableresistance window 428. When the resistance windows 428 are aligned withthe disc openings 460, the resistance windows 428 are opened to theirfullest extent allowing the resistance of the exhalant exiting the PPvalve 412 to be lower. When only a small amount of the resistancewindows 428 are aligned with the disc openings 460, the resistance ofthe exhalant exiting the PEP apparatus 410 is increased. By moving thetab setting 446 in the tab window 448, the vents may be adjusted in thedisk 417 to any of a number of positions, thereby providing acontinuously adjustable resistance. In this manner, positive expiratorypressure is controlled.

Referring again to FIG. 23, where the PEP apparatus 410 is connected atits distal end to the nebulizer 414, the operation of this embodimentwill be described. Upon inhalation, the nebulizer will provide anaerosol to the inhaling patient via the mouthpiece. A suitable nebulizerfor use with the PEP apparatus 410 is a breath-actuated nebulizer suchas disclosed in U.S. Pat. No. 6,044,841 issued Apr. 4, 2000 and entitled“Breath Actuated Nebulizer with Valve Assembly Having Relief Piston”,the entirety of which is incorporated herein by reference. Duringinhalation from the nebulizer 414, a piston 452 is drawn down bynegative pressure created by the inhalation in the nebulizer and ambientair is drawn through openings 454 in the lid 456 of the nebulizer 414.The one-way valve 459 in the PP valve assembly 412 remains shut duringinhalation.

Upon exhalation into the proximal end 430 of the mouthpiece 416, apositive pressure builds in the nebulizer 414 and the piston acts as aone-way valve to close off the flow of air out of the nebulizer. Now,the exhalant must travel through the one-way valve in the PP valveassembly 412, through the slide control and out the resistance window.Preferably the slide control 426 under the resistance window 428 hasbeen set to the appropriate position for the patient so that effectivePEP therapy may be provided. Although the PEP apparatus of FIGS. 23-27uses an aerosol delivery apparatus such as the nebulizer 414 to restrictair flow through any opening other than the PP valve assembly 412, otherembodiments, such as shown in FIG. 29 discussed below, are contemplatedwhere a second one-way valve is associated with the distal end 432 ofthe PEP apparatus 410 so that the PEP apparatus may be used in astandalone fashion for PEP therapy. The illustrated embodiment of FIGS.23-28 show an improved nebulizer 414 associated with a PEP apparatus 410having a PP valve 412. The nebulizer may be used alone or in combinationwith a mouthpiece mounted PP valve 412 or mask mounted version of the PPvalve discussed below.

FIG. 29 shows an alternative embodiment of the PEP apparatus 410 ofFIGS. 23-28 that may be used alone or coupled to a nebulizer or otheraerosol delivery apparatus. As shown in FIG. 29, the mouthpiece 462 isprovided with a one-way inhalation valve assembly 463 having a membrane464 captured in an outlet cover 465 attached to the distal end 466 ofthe mouthpiece. The flexible membrane preferably covers vents in theoutlet cover 465 during exhalation and flexes to allow fluid flow duringinhalation. As with the embodiment of FIGS. 23-28, a PP valve assembly467 is positioned on top of the mouthpiece. The PP valve assembly 467differs from the PP valve assembly 412 in FIGS. 23-28 in that the slidecontrol 468 contains a circular opening 469 that is moved by the tabsetting 469 under a tear-drop shaped resistance window 471 in the cover472. The inhalation valve 463 allows for fluid to enter the mouthpiece462 but prevents fluid from exiting the mouthpiece. The exhalation valve473 allows for exhalation through the resistance window 471 but preventsinhalation of particles or fluid. When assembled, a gap is presentbetween the exhalation valve 473 and the slide control 468 in order toallow the exhalation valve 473 to open upon exhalation. In this manner,the mouthpiece 462 is adapted to be used alone and not in conjunctionwith a nebulizer or other aerosol delivery apparatus.

Although positive expiratory devices have been shown in detail,embodiments of positive inspiratory devices are also contemplated. FIG.30 shows one embodiment, similar in concept to the embodiment of FIG.29, but with the PP valve 475 attached in series with the one-wayinhalation valve 476, rather than in series with the one-way exhalationvalve, to provide for resistance upon inhalation only. The arrows drawnin FIG. 30 depict the direction of travel from the downstream end of themouthpiece 478 to the upstream end of the mouthpiece showing that allinhalation must pass through the continuous variable resistance window480 and the port 482 of the slide control 484. If desired, in otherembodiments PP valves may be placed in series with both the one-wayinput and one-way output valves to allow for simultaneous control ofpositive inspiratory and expiratory pressures at the same or differentlevels.

As discussed above, embodiments of patient respiratory system interfacesaside from the mouthpiece configurations already disclosed arecontemplated. A PP apparatus 510 utilizing a mask 512 as the interfaceis illustrated in FIGS. 31-35. The mask may be a standard mask sized foradults or children and constructed of any of a number of materials suchas silicon rubber. The mask 512 may have a frusto-conical shaped mainsection 514 sized to cover the patient's mouth and a nosepiece section516 sized to cover a patient's nose. A central opening 518 in the mask512 may be used to attach with an aerosol delivery apparatus such as theaerosol holding chamber 14 shown in FIGS. 1-3, and other aerosoldelivery apparatus. Alternatively, the mask 512 may be fitted with aone-way valve in the central opening 518 for use as either a positiveexpiratory pressure device or a positive inspiratory pressure device. Aswith the embodiment of FIGS. 23-28 and 29-30, a PP valve assembly 520 ispositioned on the device so that inspiration and exhalation paths traveloff-axis from one another. The PP valve assembly 520 has an adjustablevalve assembly cover 534 with tab window 522 and resistance window 528openings positioned on it. The resistance window 528 is generally anoblong, tear-drop shape and the tab window 522 defines an arcuateopening in the PP valve cover 534. The tab window and resistance windowmay alternatively be rectangular, oval or any other shape. Although theabove embodiments illustrate a tab window 522 located approximately on atop surface of a mouthpiece or on top of a mask positioned approximatelyadjacent the nose, the tab window 522 may be located anywhere on themouthpiece or mask.

Referring to FIGS. 35a and 35b, the PP valve assembly 520 has a fixedopening 530 and a set of detents 532 positioned on a disk-shapedplatform 526 that connects to the nosepiece section of the mask throughcomplementary tab 542 and slot 544 connectors. As best shown in FIG.35b, the PP valve cover 534 has a protrusion 536 sized to cooperate withthe detents 532 on the platform 526 so that the valve cover may be movedto predetermined spots when the valve cover is rotated against theplatform. An axle 538 on the valve cover fits into a central opening 540in the platform 526 so that the resistance window 528 is rotatablypositionable over the exhalation port 530 and the tab window 522 linesup with the tab extending from the platform 526.

This embodiment depicts the resistance window 528 as a curved tear-droplike shape. The platform 526 is shown as a circular disc having at leastone port opening 530. The port opening 530 may vary in size and shape.The opening formed for the exhalant to pass through is related to thealignment of the resistance window 528 with the port opening 530. Inthis embodiment, the resistance window is moveably mounted relative to afixed slide control portion attached to the mask. Tabs 542 on theplatform 526 preferably mate with tab receiving regions 544 on the endof the nosepiece section 516 to retain the platform in a fixed positionrelative to the mask. Moving the tear-drop shaped resistance window 528past the part opening 530 vanes the exhalant path. In other embodiments,a plurality of resistance window openings 528 may be moved past the port530. Alternatively, there may be a plurality of ports in the slidecontrol 526.

As shown in FIGS. 31 and 32a, one end of the tear-drop shaped resistancewindow 528 matches the size of the largest port opening 530 at a maximumflow position thereby providing a maximum flow and least resistance inthat position. When the valve cover is rotated so that the resistancewindow 528 covers a greater portion of the port, as shown in FIGS.33a-33b, a smaller exhalant path is created providing greaterresistance. As shown in FIGS. 34a-34b, moving the valve cover until thetab reaches the opposite end of the tab window results in the smallestamount of the port being open, the highest airflow resistance and theleast flow. It is envisioned that a plurality of size and shape portopenings and resistance windows may be used and the disclosure is not tobe limited to that depicted in the drawings. Referring to FIG. 36, anembodiment is shown of a valve cover 550 having indicia 552representative of a resistance setting. The indicia 552 are arranged tocooperate with the tab extension 554 on the platform to indicate thecurrent resistance setting.

In alternative embodiments, PEP therapy maybe performed with amouthpiece or mask having the PP valve associated with a backpiece. Themask or mouthpiece may have an extended inlet for association with thebackpiece.

Asthmatic medications are commonly supplied in metered dose inhalers,frequently referred to as pressurized metered dose inhalers. Pressurizedmetered dose inhalers are generally cylindrical canisters with axiallyextending vent tubes from internal valves. When the external tube orstem of a pressurized metered dose inhaler canister is depressed itoperates the internal valve to dispense a measured dose of medicine fromthe stem. The medicine is commonly packed in the canister with asuitable compressed gas to propel the medicine and gas from the stem ortube when the later is depressed. The medicine may be in gas, liquid, orsolid form. The manufacturer or distributor of the pressurized metereddose inhaler canister generally supplies it with a substantiallyL-shaped adapter which receives the canister in a substantially uprightposition, and has a substantial horizontal outlet portion for receptionin the mouth of an asthmatic patient for inhalation of the medicine.

In order to address the problem of coordination and other problems knownin the art with regard to pressurized metered dose inhalers, a spacerchamber with an integrated actuator, or an aerosol holding chamber, havebeen used in attempts to overcome inappropriate particle size. Theaerosol holding chamber is generally provided at the upstream orentering end with a flexible, resilient adapter or backpiece made ofrubber or the like material. A central aperture is provided for receiptof the horizontal outlet portion of the pressurized metered dose inhaleradapter.

One embodiment provides for an improved pressurized metered dose inhaleror pressurized metered dose inhaler with an aerosol holding chamber. Asshown in FIG. 37, a PP apparatus 600 may be associated with thepressurized metered dose inhaler or the pressurized metered dose inhalerwith an aerosol holding chamber. In the PP apparatus 600 of FIGS. 37-39,an L-shaped adapter portion 602 holds the pressurized canister and ahorizontal outlet section 604 receives the medicament released inaerosol form. A one-way valve 606, which may be a flexible membrane, arigid membrane, hinged door, or other commonly known valve mechanism ispositioned at the proximal end 608 of the horizontal outlet section 604.To provide the positive expiratory pressure, the one-way valve 606permits inhalation and blocks exhalation so that substantially allexhalation is routed through the variable resistance window 610 adjacentthe one-way valve 606. A slide control 612 is movable in the resistancewindow 610 by a tab 614 to close off or open up as much of theresistance window as necessary to provide the desired expiratorypressure. FIGS. 38a and 39a illustrate the slide control in a completelyopen position and FIGS. 38b and 39b illustrate the slide control closingoff the resistance window. The slide control may maintain its positionin the resistance window through friction, detents or other knownmechanisms for mechanically retaining one of multiple desired positions.The proximal end 608 of the metered dose inhaler 600 with PPfunctionality may be used by a patient directly or fitted to an adapteron an aerosol chamber such as shown in FIG. 3. FIG. 40 illustratesanother embodiment of a pressurized metered does inhaler 620 with around proximal end 628 that may be used without the need for specialmouthpieces or aerosol holding chambers. As with the embodiment of FIGS.37-39, the alternative PEP enabled pressurized metered dose inhaler 620has a one-way valve 626 that shunts exhalant through a resistance window622 that is continuously adjustable with a slide control 624 that canadjust the aperture of the resistance window.

Generally, a mouthpiece or mask may be associated the PP apparatus. Inone configuration, an aerosol holding chamber may be attached to themouthpiece or mask end and a metered dose inhaler may be positioned on agenerally opposite end of the chamber via a backpiece. The user of thedevice may insert the mouthpiece into the mouth to obtain a dose ofmedicament. Further, the user may place the mask over the mouth and/ornose to inspire a dose of the medicament. In either situation, the maskor mouthpiece aids in the delivery of the medicament to the user.

As has been described, a method and apparatus from providing positiveexpiration or inhalation therapy, with or without separate aerosolgenerating devices, has been disclosed. In the embodiment where thepositive expiratory pressure valve is located at or near the output endof the aerosol delivery apparatus, a one way inhalation valve can belocated further downstream from the positive expiratory pressure valve.A mouthpiece and or mask can be affixed at or near the output end of theaerosol delivery apparatus. The positioning of the inhalation valveeither upstream or downstream in respect to the positive expiratorypressure valve is well known to one skilled in the art. Further, it isenvisioned that PEP therapy may be performed nasally with the positiveexpiratory pressure apparatus.

When the mouthpiece having the PP apparatus associated therewith is usedalone to perform PEP therapy, and not in conjunction with a mechanismfor the delivery of a substance, a one way inhalation valve isengageable with the mouthpiece. The inhalation valve functions so as toallow for inhalation by the patient into the mouthpiece. The exhalant ofthe patient is prevented from exiting via the inhalation valve and isdirected to exit through the PP valve. Generally, an inhalation valveopens upon inhalation to allow a fluid, such as an aerosol, to enter achamber or channel or the like but that closes upon exhalation toprevent exhaled fluids to enter into the chamber of the like. Thedrawings depict an exemplary embodiment of the one-way inhalation valvebut are not to be limiting to the embodiments shown.

One aspect of the method of use of the PP apparatus can be understood bythe following disclosure and reference to FIGS. 1-3, 5 and 9.Particularly, the arrow 2 in FIG. 1 indicates the direction of flow ofthe exhalant. The one-way valve shunts exhalant out between themouthpiece and the aerosol chamber via the continuously variableresistance window. In carrying out the method, a physician may initiallydetermine the proper resistance setting of the PP apparatus according tothe patient's requirements. One manner in which the PP apparatus may beproperly set is by attaching a fitting 39 to the mouthpiece. A manometeris then attached to the fitting port 41 and serves to measure theexpiratory pressure. A patient will exhale into the mouthpiece and thepressure can be read from the manometer. The physician can the move thetab to one of the desired settings indicated on the mouthpiece. Once theproper resistance has been determined the fitting 39 can be removed fromthe mouthpiece. This fitting 39 will not be used again unless it isdetermined that the resistance should be adjusted.

The method of performing PEP therapy using the PP apparatus includesperforming a series of breaths. When exhalation is performed, theexhalant is directed through the continuously variable expiratorywindow. Performance of a therapeutic cough triggers the loosening ofsecretions. Upon loosening of the secretions, a medicament may beprovided for inhalation into the respiratory system. In one embodimentof PEP therapy, the user will exhale into the mouthpiece and/or mask,against the desired resistance. This is done either prior to or incombination with inhalation of the medicament. The exhaled gases exitthrough the resistance window. This process may be repeated as manytimes as prescribed by the patient's physician.

As has been described, a method and apparatus for providing positiveexpiration, or inhalation, pressure therapy, with or without separateaerosol generating devices, has been disclosed. The aerosol deliveryapparatus with the PP apparatus may be used alone or in combination witha mask or mouthpiece. Also, an improved aerosol delivery apparatus withan integrated actuator has been shown, wherein the improvement comprisesa PP valve. The discussion above is descriptive, illustrative andexemplary and is not to be taken as limiting the scope defined by anyappended claims.

What is claimed is:
 1. A positive respiratory pressure apparatuscomprising: a patient respiratory system interface; a one-way valvepositionable in the patient respiratory interface and configured to passa fluid traveling in a predetermined direction from a first side to asecond side of the one-way valve; and wherein the patient respiratorysystem interface comprises a bypass window integral with, and definedby, the patient respiratory interface, the bypass window positionedadjacent the one-way valve, and wherein the patient respiratoryinterface further comprises a window opening adjustment mechanismmovably disposed in the patient respiratory system interface andoperable to change a size of an opening between the patient respiratorysystem interface and ambient air outside of the patient respiratorysystem interface, whereby the bypass window and window openingadjustment mechanism cooperate to selectively create one of a pluralityof fluid resistances.
 2. The apparatus of claim 1, wherein the bypasswindow and window opening adjustment mechanism are configured tocooperate with the one-way valve to provide an inspiratory pressure atthe patient respiratory system interface.
 3. The apparatus of claim 1,wherein the bypass window and window opening adjustment mechanism aremovable into a plurality of overlapping positions.
 4. The apparatus ofclaim 3, wherein the window opening adjustment mechanism comprises atapered portion, and wherein the size of the opening is defined by anoverlap position of the tapered portion relative to the bypass window.5. The apparatus of claim 1, wherein an edge of the window openingadjustment mechanism is movable to overlap an edge wall of the bypasswindow at a non-perpendicular angle.
 6. The apparatus of claim 1,wherein the fluid traveling in the predetermined direction comprisesinhaled gas and the one-way valve comprises a one-way inhalation valve,and wherein the one-way inhalation valve is configured to cooperate withthe bypass window and window opening adjustment mechanism to create apositive expiratory pressure at the patient respiratory systeminterface.
 7. The apparatus of claim 6, wherein the window openingadjustment mechanism is positioned over the bypass window.
 8. Theapparatus of claim 6, wherein the window opening adjustment mechanism ispositioned beneath the bypass window.
 9. The apparatus of claim 8,wherein the bypass window comprises an opening in a curved wall formedin the patient respiratory interface, and the window opening adjustmentmechanism is movably positioned adjacent the opening in the circularwall.
 10. The apparatus of claim 6, wherein the opening defined by thebypass window and window opening adjustment mechanism is continuouslyadjustable between a first exhalation resistance and a second exhalationresistance.
 11. The apparatus of claim 1, wherein the patientrespiratory system interface comprises a mouthpiece.
 12. The apparatusof claim 1, wherein the patient respiratory system interface comprises amask.
 13. The apparatus of claim 1, wherein the patient respiratorysystem interface is integrally formed with a metered dose inhaler. 14.The apparatus of claim 13, wherein the patient respiratory systeminterface defines a circular opening at a proximal end.
 15. Theapparatus of claim 13, wherein the patient respiratory system interfacedefines an oblong opening at a proximal end.
 16. The apparatus of claim13, wherein the bypass window is oriented perpendicular to the one-wayvalve.
 17. The apparatus of claim 1, wherein the one-way valve comprisesa duck-bill valve.
 18. The apparatus of claim 1, wherein the one-wayvalve comprises an annular valve.
 19. The apparatus of claim 1, furthercomprising an aerosol delivery apparatus in fluid communication with thepatient respiratory interface.
 20. The apparatus of claim 19, whereinthe aerosol delivery apparatus comprises a nebulizer.
 21. The apparatusof claim 19, wherein the aerosol delivery apparatus comprises an aerosolholding chamber.
 22. A respiratory apparatus comprising: a holdingchamber extending in a longitudinal direction and comprising input andoutput ends; a mouthpiece in fluid communication with and connected tosaid output end, wherein said mouthpiece comprises: a first annular wallarranged around and defining an inhalation passageway and extendinglongitudinally away from an output end of said mouthpiece and towardssaid holding chamber in said longitudinal direction, said first annularwall having an inner side surface and an outer side surface, whereinsaid first annular wall has a window formed therein, wherein said windowis formed by a notch defined in an edge of said first annular wall, andwherein said inner side surface of said annular wall defines an entiretyof an exhaust conduit upstream of said window; a second annular walldisposed laterally outwardly of said first annular wall and forming agap between said first and second annular walls; a one-way inhalationvalve member disposed in said inhalation passageway; and a flow controlmember extending in said longitudinal direction and positioned in saidgap between said first and second annular walls immediately adjacentsaid outer side surface of said first annular wall, wherein said flowcontrol member is moveable between a first position, wherein at least aportion of said window is open such that exhaust gases can escapethrough said window during exhalation, and a second position, whereinsaid flow control member is positioned over and closes said window. 23.The apparatus of claim 22 wherein said one-way inhalation valve memberis configured as a duck-bill valve.
 24. The apparatus of claim 22wherein said mouthpiece comprises a patient interface component and aconnector component, wherein said connector component is coupled to saidoutput end of said holding chamber.
 25. The apparatus of claim 24wherein said one-way inhalation valve comprises a base portion.
 26. Theapparatus of claim 25 wherein said base portion is secured between saidpatient interface component and said connector component.
 27. Theapparatus of claim 25 wherein said first annular wall seals against saidbase portion of said one-way inhalation valve member.
 28. The apparatusof claim 24 wherein said patient interface component and said connectorcomponent are releasably connected.
 29. The apparatus of claim 28wherein said patient interface component and said connector componentare releasably connected with a snap-fit.
 30. The apparatus of claim 22wherein said mouthpiece comprises a first opening mating with saidholding chamber and a second opening axially spaced from said firstopening, wherein said second opening is smaller than said first opening.31. The apparatus of claim 22 wherein a portion of said mouthpiece has adome- shaped interior surface.
 32. The apparatus of claim 22 whereinsaid mouthpiece comprises a mask.
 33. The apparatus of claim 22 furthercomprising a backpiece disposed at said input end, said backpiece havingan opening shaped and adapted to receive a metered dose inhaler.